NCT00975065

Brief Summary

The study design of this trial is open-label, randomized, multi-center, parallel-group study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2009

Typical duration for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

September 9, 2009

Last Update Submit

August 21, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

Galvus

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c at 24 weeks

    32weeks

Secondary Outcomes (6)

  • Hemoglobin A1c at 12 weeks

    32weeks

  • Fasting plasma glucose(Self Monitored Blood Glucose) at 24 week

    32weeks

  • 2hours post-prandial plasma glucose(Self Monitored Blood Glucose) at 24 week

    32weeks

  • Fasting Lipid profiles at 24 week

    32weeks

  • Body weight at 24 week

    32weeks

  • +1 more secondary outcomes

Study Arms (2)

Galvus group

EXPERIMENTAL

the combination of metformin plus Vildagliptin: * vildagliptin 50 mg bid plus metformin 1500mg * Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy.

Drug: vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)

Diabex group

ACTIVE COMPARATOR

metformin alone arm: * metformin 1500mg plus metformin 500mg or 1000mg * Additional SU therapy(After 12th week only under the following conditions): If A1c is ≥ 7.0% or investigator determines that the patient have metabolic problems at 12th week of therapy, investigator can prescribe additional sulfonylurea(glimepiride) to the current therapy

Drug: metformin 1500mg plus metformin 500mg or 1000mg (Diabex)

Interventions

vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex)DRUG

vildagliptin 50 mg bid plus metformin 1500mg

Galvus group
metformin 1500mg plus metformin 500mg or 1000mg (Diabex)DRUG

metformin 1500mg plus metformin 500mg or 1000mg

Diabex group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Type 2 Diabetes Mellitus who were inadequately controlled (baseline A1c of 7.0\~11.0%)on metformin monotherapy (1500mg metformin)for ≥ 2 months before baseline visit
  • Age of 18-80 years
  • Body Mass Index of 18-40 kg/m2

You may not qualify if:

  • Type 1 of diabetes
  • Myocardial Infarction, Unstable Angina, or Coronary Artery Bypass Graft within the previous 6 months
  • Congestive Heart Failure (III or NYHA class IV)
  • Liver disease such as cirrhosis or Chronic Active Hepatitis
  • History of Lacticacidemia
  • Use of any Oral Anti-diabetic Drug other than Metformin within the 2 months
  • Use of insulin before screening visit
  • ALT or AST \>3 times the upper limit of Normal range
  • Creatinine \>1.5 mg/dl
  • Other situation (pregnant or lactating females, history of drug or alcohol abuse, night-shift workers, clinically significant laboratory abnormality on screening or any medical condition that would affect the completion or outcome of the study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Handok Pharmaceuticals

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinBID protein, humanMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Sei Hyun Baik, professor

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 11, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2011

Study Completion

April 1, 2012

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

KR(1)